MAUDE Adverse Event Report: PENUMBRA, INC. RUBY COIL; HCG, KRD

Catalog Number	RBY2C1240
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of its pusher assembly.The pusher assembly was kinked approximately 5.0 cm from the proximal end.The embolization coil was intact with its pusher assembly.The introducer sheath was ovalized approximately 7.0 cm from its distal tip.The introducer sheath had coagulated blood inside the lumen.Conclusions: evaluation of the returned ruby coil revealed that the introducer sheath was ovalized and had coagulated blood throughout much of its length.If the introducer sheath is forcefully gripped or pinched during use, damage such as ovalization may occur.Based on the location of the distal tip of the coil, this ovalization likely prevented the coil from being advanced within the introducer sheath during the procedure.During the functional test, resistance was encountered while attempting to advance the ruby coil within its introducer sheath and the ruby coil could not be advanced at all.Further evaluation of the returned ruby coil revealed a kink on the pusher assembly and coagulated blood within the introducer sheath.The kink and the coagulated blood were likely incidental to the reported complaint.Penumbra coils are visually inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
Event or Problem Description
The patient was undergoing a coil embolization procedure using ruby coils.During the procedure, a ruby coil would not advance within its introducer sheath.After three failed attempts, the ruby coil was removed.The procedure was completed using a new ruby coil.There was no report of an adverse effect to the patient.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9088321
• Report Number: 3005168196-2019-01782
• Device Sequence Number: 19481117
• Product Code: HCG
• UDI-Device Identifier: 00814548019086
• UDI-Public: 00814548019086
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K173614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/24/2019
• Report Date (Section F): 01/01/2005

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 09/11/2026
• Device Catalogue Number: RBY2C1240
• Device Lot Number: F85817
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2019
• Initial Report FDA Received Date: 09/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Date Report Sent to FDA: 01/01/2005